The Recall Desk

Hazard

Device Separation recalls

89 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
89
Critical
9
Severe
50
Most recent
2026-05-13

Of the 89 device separation recalls we have scored against our rubric, 9 (10%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 50 (56%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device separation recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

51–75 of 89

  • SevereFDA (Devices)·Z-0114-2021·2020-10-28

    Stryker Trevo XP ProVue Retriever Recalled for Core Wire Fracture

    Stryker Neurovascular is recalling Trevo XP ProVue Retriever devices due to increased fracture complaints of the core wire, which can cause the stent retriever to separate and remain in the patient's vasculature.

    Product
    Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM). Procedure Pack REF: 80052, 93067, 93068, M0032PK42010001, M0033PK42022001, M0033PK43022001, M0033PK62523001, M0032PK42010002, M0032PK43010002, M0032PK62510002, M0033PK42022002, M00
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-2972-2020·2020-09-23

    Imactis Patient Fiducial Recalled Due to Component Separation Risk

    Imactis is recalling Patient Fiducial components because they may separate from the body, potentially causing navigation inaccuracies or improper needle trajectory.

    Product
    Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2725-2020·2020-08-05

    Medline Recalls ClearPro Trach T-Piece Closed Suction Catheters

    Medline is recalling 680 units of ClearPro Trach T-Piece Closed Suction Catheters because the catheter may come apart from the device assembly during use.

    Product
    ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0800-2020·2020-01-22

    Edwards Lifesciences Recalls QuickDraw Venous Cannulas Due to Connector Separation Risk

    Edwards Lifesciences is recalling QuickDraw Venous Cannulas because the device may separate from its connector if used for more than six hours, potentially causing significant blood loss.

    Product
    QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1701-2018·2018-05-23

    Ev3 MindFrame Capture Devices Recalled for Potential Wire Separation

    Micro Therapeutics is recalling MindFrame Capture LP Revascularization Devices because they may partially detach from the delivery wire.

    Product
    MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF 300011 (c) REF 300012 (d) REF 300013 (e) REF 300014 (f) REF 300015 (g) REF 300016 (h) REF 300017 (i) REF 300018 Intended to restore blood flow by removing thrombus from a large
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0928-2017·2017-01-04

    Allen Medical Systems Recalls Arthex S3 Arm Sleeve Connectors

    Allen Medical Systems is recalling 420 Arthex S3 Arm Sleeve Connectors because they may separate unexpectedly during use, potentially causing moderate injury to patients.

    Product
    Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0585-2017·2016-11-23

    C.R. Bard Recalls C-Max Cutting Loop Electrodes Due to Defect

    C.R. Bard is recalling 70 units of C-Max Cutting Loop Electrodes because the contact part could separate, affecting device functionality.

    Product
    C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, Rx only, Manufactured by: C.R. Bard, Inc., Covington, GA 30014.
    Category
    Medical Device
    Distribution
    6 states
  • CriticalFDA (Devices)·Z-1061-2016·2016-03-16

    Arrow RediGuard IAB Recall Due to Sheath Separation Risk

    Arrow International is recalling RediGuard IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1058-2016·2016-03-16

    Arrow Ultra 8 IAB Recalled for Potential Sheath Separation and Bleeding Risk

    Arrow International is recalling Ultra 8 IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1059-2016·2016-03-16

    Arrow UltraFlex IAB Recall: Sheath Separation Risk

    Arrow International is recalling UltraFlex IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases wor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1063-2016·2016-03-16

    Arrow Percutaneous Insertion Tray Recalled for Potential Sheath Separation

    Arrow International is recalling Percutaneous Insertion Trays because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1062-2016·2016-03-16

    Arrow Percutaneous Insertion Tray Recalled for Potential Sheath Separation

    Arrow International is recalling specific Percutaneous Insertion Trays because the sheath body may separate from the hub, posing a risk of bleeding.

    Product
    Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases wor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1060-2016·2016-03-16

    Arrow UltraFlex IAB Recall for Potential Sheath Separation and Bleeding Risk

    Arrow International is recalling UltraFlex IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases wor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1056-2016·2016-03-16

    Arrow Ultra 8 IAB Recalled for Potential Sheath Separation and Bleeding

    Arrow International is recalling Ultra 8 IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1057-2016·2016-03-16

    Arrow FiberOptix Ultra 8 IAB recalled for potential sheath separation

    Arrow International is recalling FiberOptix Ultra 8 IAB devices because the sheath body may separate from the hub, posing a risk of bleeding.

    Product
    FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1055-2016·2016-03-16

    Arrow FiberOptix Ultra 8 IAB Recalled for Potential Sheath Separation

    Arrow International is recalling FiberOptix Ultra 8 IAB devices because the sheath body may separate from the hub, creating a risk of bleeding.

    Product
    FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0818-2016·2016-02-24

    Smith & Nephew Recalls High Flow Irrigation Extender for Separation Risk

    Smith & Nephew is recalling 203 High Flow Irrigation Extenders because the device body may separate during surgery, potentially obstructing visualization and causing fluid leakage.

    Product
    High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the joint capsule.
    Category
    Medical Device
    Distribution
    15 states
  • SevereFDA (Devices)·Z-2369-2015·2015-08-26

    Teleflex Sheridan SHER-I Bronch Accessory Pack Recalled for Connector Defect

    Teleflex Medical is recalling Sheridan SHER-I Bronch Accessory Packs because the double swivel connector may crack or separate on the endobronchial tube.

    Product
    HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack, Rx Only, Sterile. Used to aspirate liquids or semisolids from a patient's upper airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2370-2015·2015-08-26

    Teleflex Medical Recalls Sheridan Double Swivel Connectors Due to Cracking Risk

    Teleflex Medical is recalling Sheridan double swivel connectors because they may crack or separate on endobronchial tubes.

    Product
    HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2318-2015·2015-08-12

    Cook Inc. Recalls Beacon Tip Royal Flush Plus High-Flow Catheters

    Cook Inc. is recalling Beacon Tip Royal Flush Plus High-Flow Catheters due to reports of tip splits or separation that may cause loss of function or complications.

    Product
    Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2319-2015·2015-08-12

    Cook Inc. Recalls Slip-Cath Beacon Tip Catheters Due to Tip Separation

    Cook Inc. is recalling Slip-Cath Beacon Tip Catheters because the tips may split or separate, potentially causing loss of function or complications.

    Product
    Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2093-2015·2015-07-22

    Northern Digital recalls disposable reflective marker spheres for surgical tracking

    Northern Digital Inc. is recalling 32,400 disposable reflective marker spheres used in Brainlab IGS systems due to inadequate adhesive curing that may cause the spheres to separate.

    Product
    NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1456-2015·2015-04-29

    OriGen VV13F Reinforced Dual Lumen Catheter Recalled for Separation Risk

    OriGen Biomedical is recalling 51 units of VV13F Reinforced Dual Lumen Catheters because the extension tube may separate from the hub, posing a risk of blood loss.

    Product
    OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal
    Category
    Medical Device
    Distribution
    Distributed nationwide